Technical Writer I (5625794)

Artech Information System LLC; Northborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A prominent IT staffing company in Massachusetts is seeking an experienced documentation specialist to ensure the efficient creation and review of Label & Pack documents. The successful candidate will have at least 5 years of experience in a regulated environment and a background in technical writing. Responsibilities include coordination with engineering teams, regulatory compliance support, and mentoring junior analysts. This role is essential for maintaining documentation quality and adherence to safety protocols.

Qualifications

• Minimum of 5 years of experience in a regulated environment.
• Previous experience with technical writing for manufacturing in a regulated environment.
• Use documentation controls systems to manage workflow.

Responsibilities

• Ensure timely and efficient creation/review of Label & Pack documents.
• Contribute understanding of Good Documentation Practices and Current Good Manufacturing Practices.
• Ensure a consistent style of presentation of Label and Pack documents.
• Coordinate with Engineering on tasks for validation qualification.
• Act as subject matter expert for documentation.
• Help develop OJTs for proficiency of L&P staff.
• Support readiness for regulatory inspections and compliance audits.
• Assess current documentations for Error Reduction updates.
• Support development of junior analysts through mentoring.
• Coordinate CAPA tasks with document changes.
• Revise standard operating procedures as needed.

Skills

Technical writing for manufacturing

Experience in a regulated environment

Use of documentation control systems

Education

Bachelor's degree in a related discipline

Job description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

• Ensure timely and efficient creation/review of Label & Pack documents: standard operating procedures, batch records, technical protocols and reports, etc.
• Contribute understanding of Good Documentation Practices (GDP) and Current Good Manufacturing Practices (CGMP), analytical skills, and interpretation of the information to be captured on the document
• Ensure a consistent style of presentation of Label and Pack documents to maintain quality and ease of review
• Coordinate with Engineering on tasks for validation qualification, preventative maintenance and re-qualification program processes
• Act as subject matter expert (SME) for documentation with Development and Training (D&T), and provide input in cross‑functional teams, including during Quality Assurance (QA) and Quality Control (QC)
• Help develop OJT's for proficiency of L&P staff with respect to process knowledge and critical parameters; ensure understanding and interpretation of results from tools deployed in the process
• Support readiness for regulatory inspections and compliance audits
• Assess current documentations for Error Reduction updates and ensure timely revision and review of periodic review
• Support development of junior analysts through mentoring
• Coordinate CAPA tasks with document changes for timely closure of compliance events with deviations investigators
• Revise standard operating procedures as needed
• Practice safe work habits and adhere to Sanofi's safety procedures and guideline

Skills

• Minimum of 5 years of experience in a regulated environment
• Previous experience with technical writing for manufacturing in a regulated environment
• Use of documentation controls systems to manage workflow

Qualifications

Education: Bachelor's degree in a related discipline